Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. The main questions it aims to answer are: What are the recruitment and adherence rates for a larger trial using this protocol? Is the data collection process complete and robust enough for a larger trial? What are the potential barriers to implementing a larger-scale trial? Researchers will compare vitamin D supplementation plus standard methimazole therapy to methimazole therapy alone (with participants permitted to take up to 1000 International Units of vitamin D2 daily) to explore potential effects on thyroid hormone and antibody levels. Participants will: Be randomized to either the intervention or control group. Take study medications (vitamin D or placebo) as directed. Attend regular study visits for blood tests and clinical assessments. Complete medication logs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 17
Healthy Volunteers: f
View:

• All new pediatric participants aged 9-17 years with a new diagnosis of GD who will be started on methimazole, will be offered to participate at the time of diagnosis.

• Biochemical features include:

• Suppressed TSH \<0.1.

• Elevated T3

• Elevated Free T4

• Elevated T4

• Positive TSI or TRAb. The presence of antibodies is diagnostic.

• Our study will offer enrollment to non-English speaking participants

Locations
United States
New York
Pediatric Endocrinology at Northwell Health
RECRUITING
New Hyde Park
Contact Information
Primary
Sharon Hyman, MD
Shyman1@northwell.edu
15164723750
Backup
Sofya Ilmer, MD
silmer@northwell.edu
5164723750
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 30
Treatments
Experimental: High-Dose Vitamin D2 + Methimazole
Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. In addition, they will receive high-dose vitamin D2 (ergocalciferol) 50,000 IU orally weekly for the first 8 weeks, followed by 50,000 IU orally every two weeks for the remaining 16 weeks of the study.
Placebo_comparator: Methimazole (with optional low dose Vitamin D2)
Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. Participants will have the option of taking up to 1000 IU of vitamin D2 daily, purchased over-the-counter, but this will not be provided by the study. This is to address potential vitamin D deficiency while maintaining a comparison group.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov